Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT): Replication of "Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)".

Study type
Protocol
Date of Approval
Study reference ID
18_017
Lay Summary

This protocol is part of the REPEAT Initiative, a project which samples published research studies conducted using large healthcare data (such as electronic health record or administrative claims) and replicates them by applying the publically reported methods to the same data source as the original authors. The goal is to better understand what information is missing from public reporting that prevents replication of the published results. This project will evaluate how commonly a set of specific design and analysis decisions are or are not reported in publications as well as how lack of clarity in one or more decisions impacts ability to replicate study findings. Our results will inform future policies and guidelines for reporting on healthcare database research. This protocol focuses on one sampled study: 'Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)' by Hong and colleagues. The Hong paper describes the rates of progression to diabetes among patients with impaired fasting glucose (IFG) in the UK between 2001-2012. We will replicate this study based on methods reported in the publication.

Technical Summary

This objective of this protocol is to replicate the study: 'Identification of impaired fasting glucose, healthcare utilization and progression to diabetes in the UK using the Clinical Practice Research Datalink (CPRD)' by Hong et al based on methods reported in the publication and appendices. We have created a checklist of specific study implementation parameters based on a comprehensive catalogue outlined in a consensus paper endorsed by the International Society of Pharmacoepidemiology and the International Society of Pharmacoeconomics and Outcomes research. We will start by reviewing the paper to ascertain which parameters from the catalogue are reported. We will then replicate the study population and analyses based on the study design and implementation parameters extracted during review. The Hong paper describes rates of progression to diabetes among patients with impaired fasting glucose (IFG) in the UK between 2001-2012. We will replicate this outcome. Diabetes onset was ascertained by two READ codes for diabetes or a combination of READ code for diabetes and a prescription for anti-hyperglycemic therapies. All patients were followed from the index date until the earliest of the following events: ascertainment of diabetes, death, migration out of general practice, or end of study (31 December 2012).

Health Outcomes to be Measured

Diabetes onset during follow-up.

Collaborators

Shirley Wang - Chief Investigator - Harvard University
Elisabetta Patorno - Collaborator - Brigham & Women's Hospital
Jessica Franklin - Collaborator - Brigham & Women's Hospital
Krista Huybrechts - Collaborator - Brigham & Women's Hospital
Sebastian Schneeweiss - Collaborator - Aetion, Inc

Former Collaborators

Dorothee Bartels - Chief Investigator - Boehringer-Ingelheim Germany
Andrea Meyers - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc